فريق استثنائي القوة.

F. St-Denis-Bissonnette et al. A clinically relevant large-scale biomanufacturing workflow to produce natural killer cells and natural killer cell-derived extracellular vesicles for cancer immunotherapy. Journal of Extracellular Vesicles.

لماذا يهم:We built this because EV (EVs/exosomes) therapeutics cannot reach the clinic without a production method that is both scalable and clinical-grade. We learned that a GMP-compliant, serum-free hollow-fibre bioreactor workflow can generate natural killer cells and their EVs at clinically relevant scale with full particle characterization. For BioThera, this scalable, standards-first manufacturing and characterization blueprint is the direct foundation for how we produce and verify our plant-derived EVs today.

Welsh JA, Goberdhan DCI, O'Driscoll L, Buzas EI, St-Denis-Bissonnette F, et al.; Théry C, Witwer KW. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. Journal of Extracellular Vesicles.

لماذا يهم:We took part because the EV (EVs/exosomes) field lacked a unified standard, which made results hard to compare and products hard to trust. The outcome was a global ISEV consensus defining the minimum characterization, reporting, and quality controls required to credibly call a preparation an EV product (3,043+ citations). For BioThera, the CEO being a named co-author means we do not merely comply with MISEV2023, we helped write the rulebook every credible EV product is now measured against.

F. St-Denis-Bissonnette et al. Natural killer cell-derived extracellular vesicles reprogram cellular human immunity to enhance tumor cytotoxicity. Molecular Therapy Oncology.

لماذا يهم:We ran this to test whether extracellular vesicles (EVs/exosomes) can actively reprogram recipient cells rather than act as passive cargo carriers. We learned that they can: natural killer cell EVs reprogrammed human immune cells toward enhanced tumor cytotoxicity. For BioThera, this confirms the biological premise behind our platform, that well-characterized EVs are functional messengers capable of instructing cell behaviour, and reflects the EV engineering and characterization rigor the founder brings to our plant-derived EV work.

F. St-Denis-Bissonnette et al. Evaluation of resazurin phenoxazine dye as a highly sensitive cell viability potency assay for natural killer cell-derived extracellular vesicle-based cancer biotherapeutics. Journal of Extracellular Biology.

لماذا يهم:We developed this because clinical-grade EV (EVs/exosomes) products need validated potency assays for lot release and regulatory filings (Health Canada, FDA), and that was an open methods gap. We learned that a resazurin phenoxazine dye works as a highly sensitive cell-viability potency assay for natural killer cell EV biotherapeutics. For BioThera, the same assay-development discipline underpins our batch-release testing and characterization standards, directly lowering regulatory risk as the platform scales.

F. St-Denis-Bissonnette et al. Ultracentrifugation and Ultrafiltration Differentially Alter the Composition and Functionality of the Biomolecular Corona of Extracellular Vesicles. Journal of Extracellular Biology.

لماذا يهم:We investigated this because how you isolate EVs (EVs/exosomes) may quietly change their surface and function, yet that effect was poorly characterized. We learned that ultracentrifugation and ultrafiltration differentially alter the composition and functionality of the EV biomolecular corona. For BioThera, this directly informs our process design and batch-to-batch consistency standards, since the isolation method we choose shapes the bioactive surface of the final product.

M. Kirkby, F. St-Denis-Bissonnette et al. Natural Killer Cell-Derived Extracellular Vesicles Exhibit Cytotoxicity Against Bulk Tumor Cells and Cancer Stem Cells in Triple-Negative Breast Cancer. Nanomaterials (MDPI).

لماذا يهم:We asked whether natural killer cell EVs (EVs/exosomes) could act not only against bulk tumor cells but also the treatment-resistant cancer stem cells that drive relapse. We learned that in triple-negative breast cancer models they showed cytotoxicity against both populations. For BioThera, the depth of functional EV characterization developed here reflects the analytical rigor and scalable EV biomanufacturing know-how that underpins our plant-derived EV skincare platform today.

F. St-Denis-Bissonnette et al. Scalable Biomanufacturing Workflow to Produce and Isolate Natural Killer Cell-derived Extracellular Vesicle-based Cancer Biotherapeutics. Journal of Visualized Experiments (JoVE).

لماذا يهم:We published this because a manufacturing process is only valuable to partners if it is documented reproducibly enough to transfer. The result is a peer-reviewed, step-by-step protocol to produce and isolate natural killer cell EV (EVs/exosomes) biotherapeutics. For BioThera, it confirms that our underlying production know-how is fully documented, reproducible, and ready for tech transfer and partnership.

F. St-Denis-Bissonnette et al. An Optimized Positive Staining Protocol for Clear Visualization of Extracellular Vesicles by TEM Using Uranyless and Lead Citrate. Langmuir.

لماذا يهم:We optimized this because TEM imaging is a mandatory MISEV2023 characterization step, yet the standard uranium-based stains are hazardous and inconsistently reproducible. We learned that a uranium-free positive-staining protocol (Uranyless with lead citrate) gives clear visualization of extracellular vesicles (EVs/exosomes) by TEM. For BioThera, it closes a reproducibility and safety gap in a required characterization method and keeps our characterization toolkit at the methodological frontier.